A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation

NCT00210613 | Completed Phase 3

• 1 other identifier: CR003451
• Study Type: interventional
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the study is to assess the possible withdrawal effects after abruptly stopping daily therapy with dapoxetine compared with continuing daily therapy in men with premature ejaculation (PE).

Conditions

Sexual Dysfunction; Ejaculation

Keywords

dapoxetine; premature ejaculation; sexual dysfunction; orgasmic disorder; sexual intercourse; ejaculation

Outcome Measures

Primary Outcomes (1)

• Incidence of withdrawal symptoms (defined by a checklist of signs and symptoms associated with stopping the therapy) at Weeks 9, 10, and 11 of treatment

Secondary Outcomes (1)

• Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at start of study through Week 11; adverse incidence and severity throughout study and follow up (Week 12)

Interventions

Dapoxetine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
• diagnosis of premature ejaculation (PE) according to the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for at least 6 months before study initiation
• experience PE in the majority of sexual intercourse events
• good general health at study initiation
• patient and partner willing to avoid situations or activities that may have an effect o their sexual activity (for example, avoid pregnancy, refrain from any preplanned surgery)

You may not qualify if:

• Not taken dapoxetine or participated in another study investigating pharmacologic treatment of PE within the last 3 months
• no history of any medical events such as surgery, injury, infections, or neurological conditions that are associated with the development of PE
• not taken an investigational drug within 1 month, or used an experimental medical device within 6 months, of study initiation
• no positive diagnosis of depressive or anxiety disorder, manic episode, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, schizophrenia, or other psychotic disorders
• no known allergy or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (2)

• Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. J Sex Med. 2010 Jun;7(6):2231-2242. doi: 10.1111/j.1743-6109.2010.01820.x. Epub 2010 Apr 19.

  PMID: 20412423 BACKGROUND

• McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.

  PMID: 21059176 DERIVED

Related Links

• A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Withdrawal Effects of Chronic Daily and As-Needed Dosing With Dapoxetine in the Treatment of Premature Ejaculation.

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Premature Ejaculation; Sexual Dysfunctions, Psychological; Coitus

Interventions

dapoxetine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ejaculatory Dysfunction; Genital Diseases, Male; Male Urogenital Diseases; Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2004
• Study Completion: August 1, 2005
• Last Updated: June 8, 2011

Record last verified: 2010-12